Kosten, Prijsstelling En Vergoeding Dure Geneesmiddelen. Hoe Is Het in Theorie Geregeld?

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Kosten, Prijsstelling En Vergoeding Dure Geneesmiddelen. Hoe Is Het in Theorie Geregeld? Kosten, prijsstelling en vergoeding dure geneesmiddelen. Hoe is het in theorie geregeld? KWF Kankerbestrijding September 2013 1 Inhoudsopgave Inhoudsopgave 2 Samenvatting en conclusie 5 1 Achtergrond en aanleiding 7 2 Kosten van dure oncolytica in perspectief 9 2.1 KOSTEN VOOR NIEUWVORMINGEN IN RELATIE TOT DE TOTALE ZORGKOSTEN IN NEDERLAND ................................ 9 2.1.1 KOSTEN VOOR NIEUWVORMINGEN EN ONCOLYTICA BINNEN ZVW IN RELATIE TOT TOTALE ZORGUITGAVEN IN NEDERLAND ......................................................................................................................................................... 9 2.1.2 TRENDS IN DE UITGAVEN VOOR NIEUWVORMINGEN BINNEN DE ZVW VANAF 2003 ............................................ 10 2.2 KOSTEN ONCOLOGISCHE BEHANDELINGEN .............................................................................................. 11 2.2.1 ONCOLYTICA .......................................................................................................................................... 11 2.2.2 RADIOTHERAPIE ...................................................................................................................................... 15 2.3 CONCLUSIE: KOSTEN VAN DURE GENEESMIDDELEN IN PERSPECTIEF ............................................................... 16 3 Toelating, prijsstelling en bekostiging van dure oncologische geneesmiddelen in Nederland 17 3.1 NATIONAAL NIVEAU .......................................................................................................................... 17 3.1.1 REGISTRATIE VAN HET GENEESMIDDEL EN OPNAME VAN HET GENEESMIDDEL IN HET BASISVERZEKERINGSPAKKET ..... 17 3.1.2 MAXIMUM PRIJSSTELLING DOOR FARMATEC ................................................................................................ 18 3.1.3 VERGOEDING VAN GENEESMIDDEL DOOR DE ZORGVERZEKERAAR ..................................................................... 19 3.1.4 ONDERHANDELINGEN TUSSEN DE OVERHEID EN DE FARMACEUTISCHE INDUSTRIE ............................................... 20 3.2 ZIEKENHUISNIVEAU ........................................................................................................................... 21 3.2.1 ONDERHANDELINGEN TUSSEN HET ZIEKENHUIS EN DE FARMACEUTISCHE INDUSTRIE OVER GENEESMIDDELEN .......... 21 3.2.2 DE VERGOEDING DIE HET ZIEKENHUIS ONTVANGT VAN DE ZORGVERZEKERAAR ................................................... 22 3.2.3 BUDGETTAIR KADER ZORG GEEFT EEN PLAFOND VOOR TOTALE KOSTEN ............................................................ 22 3.3 CONCLUSIE ...................................................................................................................................... 22 4 Prijsstelling internationaal 24 4.1 NAAR VALUE BASED PRICING IN ENGELAND ............................................................................................. 24 4.2 IN FRANKRIJK ONDERHANDELT CEPS OVER DE PRIJZEN .............................................................................. 27 4.3 DUITSLAND REGULEERT ZIJN PRIJZEN MET AMNOG ................................................................................. 28 4.4 IN NOORWEGEN KOOPT HET LIS NATIONAAL IN ....................................................................................... 30 4.5 BIJZONDERE VERSCHILLEN EN CONCLUSIE ............................................................................................... 32 4.5.1 REGULATIE VAN PRIJZEN VIA MAXIMUMPRIJZEN VAN REFERENTIELANDEN OF VIA WINST VAN FARMACEUTEN .......... 32 4.5.2 INKOOP VAN KLINISCHE GENEESMIDDELEN: CENTRAAL OF DECENTRAAL ............................................................ 33 4.5.3 EFFECT VAN BELEID OP TOEGANKELIJKHEID EN PRIJS ...................................................................................... 33 4.5.4 CONCLUSIE INTERNATIONALE VERGELIJKING ................................................................................................ 33 2 5 Factoren die kunnen leiden tot belemmeringen in de toegankelijkheid van dure geneesmiddelen 34 5.1 MOGELIJKE BELEMMERINGEN IN TOEGANKELIJKHEID OP NATIONAAL NIVEAU .................................................. 34 5.1.1 GENEESMIDDEL WORDT NIET OPGENOMEN IN HET BASISPAKKET ..................................................................... 34 5.1.2 VERMINDERDE BESCHIKBAARHEID VAN GENEESMIDDELEN IN NEDERLAND ........................................................ 35 5.2 MOGELIJKE OORZAKEN VOOR VARIATIE VAN TOEGANKELIJKHEID OP ZIEKENHUISNIVEAU ................................... 35 5.2.1 ONDERHANDELINGEN TUSSEN HET ZIEKENHUIS EN ZORGVERZEKERAAR ............................................................. 35 5.2.2 INTERNE AFSPRAKEN OVER DE VERDELING VAN HET BUDGET ........................................................................... 37 5.2.3 ONDERHANDELINGEN ZIEKENHUIS MET FARMACEUTISCHE INDUSTRIE .............................................................. 37 5.3 MOGELIJKE OORZAKEN WAARDOOR EEN PATIËNT NIET DE MEEST EFFECTIEVE BEHANDELING KRIJGT ..................... 38 5.3.1 KENNIS: RICHTLIJNEN VEROUDERD OF NIET EENDUIDIG .................................................................................. 38 5.3.2 DIAGNOSTISCHE TESTS WORDEN NIET ALTIJD INGEZET ................................................................................... 39 5.4 CONCLUSIE ...................................................................................................................................... 40 6 Aanbevelingen en oplossingsrichtingen 41 6.1 OPLOSSINGSRICHTINGEN OM GELIJKE TOEGANG TOT DURE GENEESMIDDELEN TE BEVORDEREN .............................. 41 6.1.1 HELDERE CRITERIA OVER TOELATING TOT PAKKET .......................................................................................... 41 6.1.2 LAGERE PRIJS PER GENEESMIDDEL .............................................................................................................. 41 6.1.3 TERUGDRINGEN ONGEWENSTE VARIATIE OP PATIËNTNIVEAU .......................................................................... 42 6.2 AANBEVELINGEN VOOR VERVOLGSTAPPEN KWF ...................................................................................... 43 7 Referenties 44 8 Bijlagen 48 BIJLAGE 1: DEFINITIELIJST ............................................................................................................................ 48 BIJLAGE 2: LIJST DURE GENEESMIDDELEN ........................................................................................................ 50 BIJLAGE 3: OVERHEVELING ONCOLYTICA IN 2013 EN 2014 ................................................................................. 51 BIJLAGE 4: LIJST GEÏNTERVIEWDE / GESPROKEN PERSONEN ................................................................................. 52 BIJLAGE 5: CONTINUE MONITORING DURE ONCOLYTICA VIA KOPPELING VEKTIS EN NKR ........................................... 53 BIJLAGE 6: KOSTEN VAN ONCOLYTICA IN NEDERLAND, NAAR ATC CODE ................................................................ 54 Disclaimer © 2013 KPMG Advisory N.V., ingeschreven bij het handelsregister in Nederland onder nummer 33263682, is een dochtermaatschappij van KPMG Europe LLP en lid van het KPMG-netwerk van zelfstandige ondernemingen die verbonden zijn aan KPMG International Cooperative (‘KPMG International’), een Zwitserse entiteit. Alle rechten voorbehouden. Gedrukt in Nederland. De naam KPMG, het logo en ‘cutting through complexity’ zijn geregistreerde merken van KPMG International. Dit rapport is uitsluitend bestemd voor u als opdrachtgever van het onderhavige onderzoek en voor de SCK-werkgroep. Zonder onze uitdrukkelijke en voorafgaande schriftelijke toestemming is het niet toegestaan dit rapport dan wel delen daaruit te bewerken, wijzigen of te gebruiken voor andere doeleinden, openbaar te maken of aan derden (niet zijnde de SCK-werkgroep) te verstrekken. KPMG aanvaardt geen aansprakelijkheid voor het gebruik van dit rapport anders dan waarvoor het is opgesteld en aan u als opdrachtgever en de SCK-werkgroep beschikbaar is gesteld. Opdrachtgever houdt KPMG schadeloos tegen, en compenseert KPMG voor alle schade, die wordt veroorzaakt door of verband houdt met het verstrekken van dit rapport aan derden anders dan waarvoor het is opgesteld. De in dit document vervatte informatie is van algemene aard en is niet toegespitst op de specifieke omstandigheden van een bepaalde persoon of entiteit. Wij streven ernaar juiste en tijdige informatie te verstrekken. Wij kunnen echter geen garantie geven dat dergelijke informatie op de datum waarop zij wordt ontvangen nog juist is of in de toekomst blijft. Daarom adviseren wij u op grond van deze informatie geen beslissingen te nemen behoudens op grond van advies van deskundigen na een grondig onderzoek van de desbetreffende situatie.” 3 4 Samenvatting en conclusie In de afgelopen decennia zijn interessante en hoopgevende geneesmiddelen op de markt gekomen voor de behandeling van kanker. Deze middelen zijn bijna allemaal erg duur. Er zijn signalen dat mogelijk niet alle patiënten in Nederland gelijke toegang hebben tot deze medicijnen. Een van de oorzaken hiervan zou de prijsstelling en vergoeding van deze medicijnen kunnen zijn. KWF wil graag de signalen van de mogelijke onderbehandeling van kankerpatiënten met dure geneesmiddelen nader onderzoeken. KWF Kankerbestrijding heeft hiervoor KPMG Plexus gevraagd een deel van dit onderzoek voor de SCK- werkgroep Dure Geneesmiddelen uit te voeren, met name op het gebied van prijsstelling en
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